CN111918606A - Catheter with staggered electrode spine assembly - Google Patents

Abstract

An electrophysiology catheter having a distal electrode assembly with a covered spine carrying a plurality of microelectrodes. The position of the microelectrodes on each ridge is staggered with respect to the microelectrodes on adjacent ridges to minimize the risk of the electrodes on adjacent ridges touching each other during use of the catheter. The staggered electrode configuration provides a larger effective contact surface for the distal electrode assembly because the effective concentric electrode array is increased or at least doubled.

Description

Catheter with staggered electrode spine assembly

technical field

The present invention relates to an electrophysiological catheter, and in particular, to a cardiac electrophysiological catheter having an electrode configuration that provides more accurate and independent sensing of graded signals.

Background technique

Leads have been commonly used in medical practice for many years. They are used to stimulate and map electrical activity in the heart, and to ablate sites of abnormal electrical activity.

In use, the lead is inserted into a major vein or artery (eg, the femoral artery) and then introduced into the chamber of the heart of interest. Once the catheter is positioned within the heart, the location of abnormal electrical activity within the heart is located.

One localization technique involves electrophysiological mapping procedures whereby electrical signals emanating from conductive intracardiac tissue are systematically monitored and maps are formed from these signals. By analyzing this map, the physician can identify interfering electrical pathways. A conventional method for mapping electrical signals from conductive cardiac tissue is to introduce an electrophysiological catheter (electrode catheter) percutaneously with a mapping electrode mounted on its distal tip. The catheter is manipulated to place these electrodes in contact with the endocardium. By monitoring electrical signals at the endocardium, the site of abnormally conductive tissue that causes arrhythmias can be pinpointed.

For sensing by a ring electrode mounted on the catheter, the lead wire transmitting the signal from the ring electrode is electrically connected to a suitable connector in the distal end of the catheter control handle that is electrically connected to the ECG monitoring system and/or Suitable 3D electrophysiological (EP) mapping systems such as CARTO, CARTO XP or CARTO 3 from Biosense Webster, Inc. (Irwindale, California).

Smaller and more closely spaced electrode pairs allow for more accurate detection of near-field potentials relative to far-field signals, which can be important when trying to address specific regions of the heart. For example, the near-field pulmonary vein potential is a very small signal, whereas the atria, located very close to the pulmonary veins, provide a much larger signal. Therefore, even when the catheter is placed in the pulmonary vein region, it may be difficult for an electrophysiologist to determine whether the signal is a small near potential (from the pulmonary vein) or a larger, more distant potential (from the atrium). Smaller and closely spaced bipolars allow physicians to more accurately remove far-field signals and obtain more accurate readings of electrical activity in local tissue. Thus, by having smaller and closely spaced electrodes, the location of myocardial tissue with pulmonary venous potential can be precisely targeted, and thus allow clinicians to deliver therapy to specific tissues. In addition, smaller and closely spaced electrodes allow physicians to determine the precise anatomical location of the hilum via electrical signals.

Increasing electrode density (eg, by increasing the number of electrodes carried on the catheter) also improves detection accuracy. However, the more electrodes that are carried on the catheter, especially the higher the electrode density, the greater the risk of electrode touching and shorting. Furthermore, it is always desirable to improve electrode tissue contact with highly flexible electrode assembly structures that can make contact reliably but in a manner that allows the electrode carrying structure to function in a controlled and predictable manner without piercing or damaging tissue . As the materials used to construct these structures become more flexible and delicate, the risk of deformation, especially elongation, of the smaller ring electrodes and their supporting structures increases during catheter assembly. Furthermore, as electrode assembly structures become finer, the risk of component separation, kinking, and entanglement increases.

It has also been observed that signal acquisition through the electrodes is adversely affected when the electrodes touch or come into contact with each other. During mapping, contacts and collisions may occur as the operator manipulates the distal electrode assembly of the catheter, especially as the operator "sweeps" the assembly along the tissue surface. Contact and collision between electrodes can produce artifacts that adversely affect ECG signal quality and map generation.

Therefore, electrophysiological catheters with closely spaced microelectrodes to achieve high electrode density are required. There is also a need for electrophysiological catheters with electrode bearing structures that are finely constructed to provide the desired flexibility, but whose movement is predictable upon tissue contact. There is also a need for electrophysiological catheters that minimize the risk of electrode touching and shorting.

SUMMARY OF THE INVENTION

The present invention relates to an electrophysiological catheter having a distal electrode assembly carrying very small and closely spaced microelectrodes on a plurality of discrete ridges that can be flexibly stretched over a tissue surface area for simultaneous Signals are detected at the location while minimizing the detection of undesired noise, including far-field signals. The distal electrode assembly is configured to conform to different anatomies of tissue in the atrial cavity of the heart. Ridges have curvilinear sections or curvilinear sections with straight sections for a wide range of adaptability to different tissue surfaces, while providing mechanical advantages in different sections to improve flexibility and rigidity for better contact organize. Each ridge has a generally tapered configuration from its proximal end to its distal end for providing a stronger, more rigid proximal base and a more flexible distal end for improved flexibility characteristics, At the same time the risk of ridges touching or tangling is minimized.

In some embodiments, the electrophysiological catheter has an elongated body and a distal electrode assembly. The distal electrode assembly has a proximal stem, a plurality of ridges emanating from the proximal stem, and a plurality of non-conductive ridge covers, each ridge cover surrounding a corresponding ridge, each ridge cover having a sidewall embedded in the cover Multiple tensile members in .

In some embodiments, the tensile members extend in the longitudinal direction.

In some embodiments, the tensile member has portions that extend in the longitudinal direction.

In some embodiments, the tensile member includes a wire.

In some embodiments, the tensile member includes fibers.

In some embodiments, the electrophysiological catheter has an elongated body and a distal electrode assembly. The distal electrode assembly has a proximal stem and a plurality of ridges, each ridge having an enlarged distal portion having a through hole. The distal electrode assembly also has a plurality of non-conductive ridge covers, each ridge cover surrounding a corresponding ridge. The distal electrode assembly also has a cap cover enclosing the enlarged distal portion, the cap cover having a portion extending through the through hole.

In some embodiments, the electrophysiological catheter has an elongated body and a distal electrode assembly. The distal electrode assembly has a proximal stem and a plurality of ridges in number of at least eight, each ridge having a first segment and a linear segment, the first segment having a first pre-shaped curvature defined by a first radius. The distal electrode assembly also has a plurality of non-conductive ridge covers and a plurality of microelectrodes, with at least one microelectrode on each ridge.

In some embodiments, each ridge includes a second segment having a second preformed curvature defined by a second radius different from the first radius, the second segment having the second preformed curvature The segment is distal to the first segment having the first preformed curvature.

In some embodiments, the first radius is smaller than the second radius.

In some embodiments, the second preform curvature is opposite to the first preform curvature.

In some embodiments, the second segment having the second preformed curvature is distal to the first segment having the first preformed curvature.

In some embodiments, the linear segment is located between a first segment having a first preformed curvature and a second segment having a second preformed curvature.

In some embodiments, the second segment having the linear segment is distal to the second segment having the second preformed curvature.

In some embodiments, each covered ridge has an outer perimeter of less than 3 French.

In some embodiments, the outer perimeter is about 2.6 French.

In some embodiments, the electrophysiological catheter has an elongated body and a distal electrode assembly. The distal electrode assembly has a proximal portion and a plurality of ridges, each ridge having a linear taper with a wider proximal end and a narrower distal end. The distal electrode assembly also has a plurality of non-conductive ridge covers, each non-conductive ridge cover surrounding a corresponding ridge.

In some embodiments, the linear taper is continuous.

In some embodiments, the linear taper is discontinuous.

In some embodiments, the discontinuous linear taper includes a concave portion having a width that is less than the width of the more proximal rod and the width of the more distal portion.

In some embodiments, the spine has hinges along the lateral edges configured for in-plane deflection of the spine.

In some embodiments, the electrophysiological catheter has an elongated body and a distal electrode assembly. The distal electrode assembly has a proximal rod, a plurality of ridges in number of at least eight, each ridge having a linear taper having a wider proximal end and a narrower distal end. The distal electrode assembly also has a plurality of non-conductive ridge covers, each non-conductive cover surrounding a corresponding ridge. The distal electrode assembly also has a plurality of microelectrodes, the plurality being at least about 48, each microelectrode having a length of about 480 μm.

In some embodiments, the microelectrodes on each ridge are separated by a distance ranging between about 1 mm and 3 mm as measured between the leading edges of the microelectrodes.

In some embodiments, the distance is about 2 mm.

In some embodiments, the microelectrodes on each ridge are arranged as bipolar pairs, wherein the leading edges of the microelectrodes within a pair are separated by a first distance ranging between about 1 mm and 3 mm, and wherein the leading edges of the front microelectrodes between the pairs are separated by a second distance ranging between 1 mm and 6 mm.

In some embodiments, the first distance is about 2 mm and the second distance is about 6 mm.

In some embodiments, the plurality of microelectrodes equals about 64.

In some embodiments, the plurality of microelectrodes equals about 72.

In some embodiments, the first ring electrode is carried on the proximal stem of the distal electrode assembly, and the second and third ring electrodes are carried on the distal portion of the elongated body.

In some embodiments, the electrophysiological catheter has an elongated body and a distal electrode assembly. The distal electrode assembly has a proximal rod that defines a perimeter about the longitudinal axis. The distal electrode assembly also has a plurality of ridges emanating from the proximal shaft and diverging at its distal end, the plurality of ridges alternating between first and second ridges around the circumference of the shaft. The distal electrode assembly also has a plurality of non-conductive ridge covers and a plurality of microelectrodes, each ridge cover surrounding a corresponding ridge, the plurality of microelectrodes having a staggered configuration with respect to the first and second ridges, wherein each The proximal-most microelectrodes on the first ridge were positioned at a greater distance from the proximal rod, and the proximal-most electrodes on each second ridge were positioned at a smaller distance from the proximal rod.

The staggered electrode configuration provides a larger effective contact surface for the distal electrode assembly because the effective concentric electrode array is increased or at least doubled.

In some embodiments, the distal electrode assembly includes at least four first ridges and four second ridges, and each ridge carries eight microelectrodes.

In some embodiments, each microelectrode has a length of about 480 μm.

In some embodiments, the microelectrodes on each ridge are separated by a distance ranging between about 1 mm and 3 mm as measured between the leading edges of the microelectrodes.

In some embodiments, the distance is about 2 mm.

In some embodiments, the microelectrodes on each ridge are arranged as bipolar pairs, wherein the leading edges of the microelectrodes within a pair are separated by a first distance ranging between about 1 mm and 3 mm, and wherein the leading edges of the front microelectrodes between the pairs are separated by a second distance ranging between 1 mm and 6 mm.

In some embodiments, the first distance is about 2 mm and the second distance is about 6 mm.

In some embodiments, the electrophysiological catheter has an elongated body and a distal electrode assembly. The distal electrode assembly has a support structure having a proximal stem having a sidewall having an inner surface defining a lumen, the sidewall having an opening. The support structure also has a plurality of ridges emanating from the proximal rod and diverging at its distal end, and a plurality of non-conductive covers, each non-conductive cover surrounding a respective ridge. The distal electrode assembly also has a plurality of microelectrodes on each ridge, and a housing insert received in the lumen of the stem, the housing insert having an outer surface that remains between the outer and inner surfaces of the stem There are gaps. Adhesive fills the gap between the inner surface of the proximal rod and the outer surface of the housing insert, the adhesive having a portion passing through the opening in the sidewall of the proximal rod.

In some embodiments, the housing insert has a lumen having an elongated kidney bean-shaped configuration in cross-section.

In some embodiments, the housing insert has a lumen having a C-shaped configuration in cross-section.

In some embodiments, an opening in the proximal rod provides visual access into the lumen of the rod for inspection of components extending therethrough during assembly. Additionally, the void-filling adhesive is injected or otherwise applied through the opening.

Description of drawings

These and other features and advantages of the present invention will be better understood by reference to the following detailed description when considered in conjunction with the accompanying drawings. It should be understood that selected structures and features have not been shown in some of the drawings in order to provide a better view of the remaining structures and features.

Figure 1 is a perspective view of a catheter of the present invention according to one embodiment.

FIG. 2 is an end cross-sectional view of a catheter body of the catheter of FIG. 1 .

FIG. 3 is an end cross-sectional view of the deflection section of the catheter of FIG. 1 .

4 is a perspective view of a unitary support member according to one embodiment.

5A is a side view of a unitary support member according to one embodiment.

Figure 5B is a detailed view of the one-piece support member of Figure 5A.

5C is an end cross-sectional view of the unitary support member of FIG. 5A taken along line C-C.

Figure 5D is a detailed view of an enlarged distal portion of the ridge of Figure 5A.

5E is a detailed view of an end cross-sectional view of the ridge of FIG. 5A.

6A is a side view of a unitary support member according to one embodiment.

Figure 6B is a detailed view of the one-piece support member of Figure 6A.

Figure 6C is a detailed view of the distal portion of the spine of Figure 6B.

Figure 6D is a detailed view of an enlarged distal portion of the ridge of Figure 6A.

6E is an end cross-sectional view of the unitary support member of FIG. 6B taken along line E-E.

Figure 6F is a detailed view of an end cross-sectional view of the proximal portion of the ridge of Figure 6B.

Figure 6G is a detailed view of an end cutaway view of the distal portion of the spine of Figure 6B.

7A is a side view of a unitary support member according to one embodiment.

Figure 7B is a side view of the unitary support member of Figure 7A with the support member in contact with tissue.

8A is a side view of a unitary support member according to another embodiment.

8B is a side view of the unitary support member of FIG. 8A with the support member in contact with tissue.

9A is a side view of a unitary support member according to another embodiment.

9B is a side view of the unitary support member of FIG. 9A with the support member in contact with tissue.

10 is a side view of a unitary support member, shown to illustrate various parameters, according to one embodiment.

11A is a top plan view of a ridge with a hinge structure, according to one embodiment.

11B is a top plan view of a ridge with a hinge structure according to another embodiment.

12A is a side view of a covered ridge according to one embodiment.

12B is a side view of a covered ridge according to another embodiment.

13 is a front view of a distal electrode assembly according to one embodiment.

14A is a side cross-sectional view of the junction between the deflection segment and the distal electrode assembly, according to one embodiment.

Figure 14B is an end cross-sectional view of the housing insert of Figure 14A.

15A is a side cross-sectional view of the junction between the deflection segment and the distal electrode assembly, according to another embodiment.

Figure 15B is an end cross-sectional view of the housing insert of Figure 15A.

16 is a side perspective view of a covered ridge with reinforcing tensile members, according to one embodiment.

17 is a detailed side cross-sectional view of a portion of a joint with reinforcing tensile members, according to one embodiment.

18 is an end cross-sectional view of a shell insert with reinforcing tensile members therethrough, according to one embodiment.

19 is an end cross-sectional view of a deflection segment having a reinforcing tensile member therethrough, according to one embodiment.

20 is an end cross-sectional view of a catheter body having a reinforcing tensile member therethrough, according to one embodiment.

21 is a schematic illustration of a heart and placement of a catheter of the present invention for tissue contact, according to various embodiments.

22 is a schematic illustration of a distal electrode assembly in contact with tissue in a pulmonary vein, according to one embodiment.

23 is a schematic illustration of a distal electrode assembly in contact with tissue of the sidewall of the heart, according to one embodiment.

24 is a schematic illustration of a distal electrode assembly in contact with tissue of the inferior wall or apex of the heart, according to one embodiment.

25 is an end cross-sectional view of the distal end of the distal electrode assembly of FIG. 15A taken along line A-A.

26 is a schematic illustration of concentricity of a distal electrode assembly according to one embodiment.

27 is a schematic illustration of concentricity of a distal electrode assembly according to another embodiment.

Detailed ways

Referring to FIG. 1 , in some embodiments of the present invention, a catheter 10 includes a catheter body 12 , an intermediate deflection section 14 , a distal electrode assembly 15 , and a control handle 16 proximal to the catheter body 12 . The distal electrode assembly 15 includes a plurality of ridges 17 each supporting a plurality of microelectrodes 18 .

In some embodiments, the catheter body 12 includes an elongated tubular configuration having a single axial lumen or central lumen 19, as shown in FIG. 2 . The catheter body 12 is flexible, ie bendable, but substantially incompressible along its length. The catheter body 12 may have any suitable configuration and may be made of any suitable material. The presently preferred construction includes an outer wall 20 made of polyurethane or PEBAX. The outer wall 20 includes an embedded braided mesh made of high strength steel, stainless steel, etc. to increase the torsional stiffness of the catheter body 12 so that when the control handle 16 is rotated, the deflection segment 14 of the catheter 10 rotates in a corresponding manner.

The outer diameter of the catheter body 12 is not critical. Likewise, the thickness of the outer wall 20 is not critical, but is thin enough that the central lumen 19 can accommodate components including, for example, one or more puller wires, electrode leads, irrigation tubes, and any other wires and/or cables Wire. In some embodiments, the inner surface of the outer wall 20 is lined with a rigid tube 21, which may be made of any suitable material, such as polyimide or nylon. The rigid tube 21 in conjunction with the braided outer wall 20 provides improved torsional stability while minimizing the wall thickness of the catheter, thus maximizing the diameter of the central lumen 19 . As those skilled in the art will recognize, the catheter body configuration can be modified as desired. For example, rigid tubes can be removed.

In some embodiments, the intermediate deflection section includes a shorter section of tube 30 , as shown in FIG. 3 , having a plurality of lumens 31 . In some embodiments, the tube 30 is made of a suitable biocompatible material that is more flexible than the catheter body 12 . A suitable material for the tube 19 is woven polyurethane, ie polyurethane with an embedded mesh of woven high strength steel, stainless steel or the like. The outer diameter of the deflection segment 14 is similar to the outer diameter of the catheter body 12 . The number and size of lumens is not critical and can vary depending on the application.

Various components extend through the catheter 10 . In some embodiments, these components include lead wire 22 for distal electrode assembly 15 , one or more puller wires 23A and 23B for deflecting deflection segment 14 , Cable 24 of electromagnetic position sensor 26 (see Figures 14A and 15A) at or near the distal end. In some embodiments, the catheter includes an irrigation tube 27 for delivering fluid to the distal end of the deflection segment 14 . These components pass through the central lumen 19 of the catheter body 12 as shown in FIG. 2 .

In the deflection segment 14, different components pass through different lumens 31 of the tube 30, as shown in FIG. In some embodiments, lead 22 is passed through one or more lumens 31A, first puller wire 23A is passed through lumen 31B, cable 24 is passed through lumen 31C, and second puller wire 23B is passed through lumen 31D , and the irrigation tube 27 passes through the lumen 31E. Lumen 31B and lumens 31D are diametrically opposed to each other to provide bidirectional deflection of intermediate deflection segment 14 . Additional components may pass through additional lumens or share lumens with other aforementioned components, as desired.

Distal of the deflection segment 14 is a distal electrode assembly 15 that includes an integral support member 40 as shown in FIG. 4 . In some embodiments, the unitary support member 40 comprises a superelastic material with shape memory, ie, can temporarily straighten or flex from its original shape upon application of force, and can substantially recover when no force or force is removed hyperelastic material to its original shape. One suitable material for the support member is a nickel/titanium alloy. Such alloys typically include about 55% nickel and 45% titanium, but can also include about 54% to about 57% nickel, with the remainder titanium. The nickel/titanium alloy is Nitinol with excellent shape memory and ductility, strength, corrosion resistance, resistivity and temperature stability.

In some embodiments, member 40 is constructed and shaped from an elongated hollow cylindrical member, eg, with portions cut (eg, by laser cutting) or otherwise removed, to An elongated body forming a proximal portion or rod 42 and a ridge 17 emanating longitudinally from the rod and spanning outwardly from the rod. The rod 42 defines a lumen 43 therethrough for receiving the distal portion 30D of the multi-lumen tube 30 of the deflection segment 14 (see FIG. 14A ), as well as various components, as discussed further below, which are housed in Rod 42 extends in or through lumen 43 .

Each ridge 17 of member 40 has an enlarged distal portion 46, and each ridge has a wider proximal end and a narrower distal end. In some embodiments, as shown in Figures 5A, 5B, 5C, 5D, and 5E, the ridges are linearly tapered to achieve "out-of-plane" flexibility along their length (see Figure 5E Arrow A1 ), including increased flexibility towards the distal end 48 . In some embodiments, the one or more ridges 17 have a proximal portion 17P having a uniform width W1 , a distal portion 17D1 having a continuous linear taper defined by a line of taper T1 (see FIG. 5B ), and having a width less than W1 The more distal portion 17D2 of the uniform width W2. The distal portion 17D1 has a continuously increasing flexibility such that as the distal portion 46 comes into contact with tissue, the ridges can assume a predetermined form or curvature. The resulting ridges having a relatively rigid proximal portion and a relatively more flexible distal portion help prevent the ridges from crossing and overlapping each other during use.

In some embodiments, one or more ridges 17 have a discontinuous linear taper between end 41 and end 46, as shown in Figures 6A, 6B, 6C, 6D, 6E, 6F, and 6G shown in. The discontinuous linear taper includes one or more narrower or recessed portions 50 strategically positioned along the ridge to interrupt the otherwise continuous linearity defined by the taper T2 between the rod 42 and the enlarged distal portion 46 taper. Each recessed portion 50 has a width W (see FIG. 6C ) that is less than the width WD of the more distal portion and also less than the width WP of the more proximal portion, where width WD < width WP. Thus, each recessed portion 50 advantageously allows this region of the spine to have a different flexibility than the immediately adjacent (distal and proximal) portions 51 of the spine, and provides a degree of flexibility between the portions separated by the recessed portion 50 independent flexibility (see Figure 6B). Thus, when the distal portion 46 is in contact with tissue, the ridges are allowed to exhibit significantly greater flexibility in this area of the recessed portion 50 relative to the portion 51 of the ridges, and thus a tighter or sharper curvature.

In some embodiments, each ridge (between the distal end of rod 42 and the distal end of the ridge) has between about 1.0 cm and 2.5 cm, or between about 1.50 cm and 2.0 cm A length in the range between, and a width in the range between about 0.009 inches and 0.02 inches. In some embodiments, the concave portion 50 has a length ranging between about 10% to 20% of the length of the ridge, and a width ranging between about 50% to 80% of the immediately adjacent width W, measured from the distal end of the rod 42, the proximal leading edge of the concave portion is located about 55% to 65% of the length of the ridge.

To further facilitate contact of the microelectrodes with tissue along the entire length of the ridges, each ridge 17 has a pre-shaped configuration or curvature achieved by, for example, heating and molding a jig. The one or more ridges 17 have at least two different pre-formed curvatures C1 and C2, as shown in FIG. 7A , wherein section S1 with pre-formed curvature C1 is defined by radius R1 and section S2 with pre-formed curvature C2 Defined by radius R2, where radius R1 < R2 and curvatures C1 and C2 are generally in opposite directions to each other, the ridges of integral support member 40 have generally forward facing concavities similar to an open umbrella. As shown in Figure 7B (only two ridges are shown for clarity), the pre-formed ridges move from their neutral configuration N (shown in phantom) when the distal ends of the ridges come into contact with the exemplary surface SF ) into their adaptive or temporary "deformed" configuration A, which may include a "crouching" profile (compared to their neutral configuration) that may be more suitable for areas with undulations of cardiac tissue . Advantageously, the one-piece support member 40 retains its generally forward facing concave configuration and does not turn inside out upon tissue contact (like an umbrella that turns up in a strong wind).

In some embodiments, the one or more ridges 17 have at least curvilinear sections and linear sections. In some embodiments, the one or more ridges have at least two different preformed curvatures along their length. For example, as shown in FIG. 8A, one or more ridges 17 have a first section SA, a second section SB, and a third section SC, wherein the first section SA has a preformed curvature CA defined by a radius RA, The second section SB has a preformed curvature CB defined by a radius RB, and the third section SC is linear, where radius RA < radius RB. As shown in Figure 8B (only two ridges are shown for clarity), the pre-formed ridges transition from their neutral configuration N to their adaptation when the distal ends of the ridges come into contact with the exemplary surface SF Sexually or temporarily "deformed" configuration A, which may include deeper concavities (compared to their neutral configurations) that may be more suitable for regions of the heart tissue with convexities.

As another example, as shown in FIG. 9A, one or more ridges 17D have a first section SJ, a second section SK, and a third section SL, wherein the first section SJ has a preform defined by a radius RJ The curvature CJ, the second section SK is linear, and the third section SL has a preformed curvature CL defined by a radius RL, where radius RJ < radius RL. As shown in Figure 9B (only two ridges are shown for clarity), the pre-formed ridges transition from their neutral configuration N to their adaptation when the distal ends of the ridges come into contact with the exemplary surface SF Sexually or temporarily "deformed" configuration A, which may include a lower profile (compared to their neutral configuration) that may be more suitable for flatter regions of cardiac tissue.

10, in some embodiments, the integral support member 40 and its spine 17 may be defined by a number of parameters, including, for example, the following parameters:

a = height of second curvature, in the range between about 0.00 inches and 0.050 inches

b = distal length of the second curvature, in the range between about 0.302 inches and 0.694 inches

c=proximal length of second curvature in the range between about 0.00 inches and 0.302 inches

d = distance between first curvature and second curvature, in the range between about 0.00 inches and 0.170 inches

e = first radius of curvature, in the range between about 0.075 inches and 0.100 inches

f = length of segment with uniform width, about 0.100 inches

g = depth of concave, in the range between about 0.123 inches and 0.590 inches

Notably, in some embodiments of the unitary support member 40, the proximal (or first) pre-formed curvature is opposite to the distal (or second) pre-formed curvature, so that the ridges 17 of the distal electrode assembly 15 can be Maintaining its generally concave surface and facing forward without reversal upon tissue contact, the highly flexible spine allows flexibility or "stretchability" of the assembly, which prevents the distal tip of the spine from contacting tissue and when The distal electrode assembly is pressed against the tissue surface to ensure that the tissue is pierced or otherwise damaged when contacted by each of the ridges 17 . Additionally, in some embodiments, the concave portion 50 may span between the proximal pre-formed curvature and the distal pre-formed curvature such that the three portions of the spine (proximal, concave, and distal) Each may behave differently in response to tissue contact and the associated pressure exerted by the operating user of the catheter and have a degree of independence from each other in terms of flexibility.

It should be understood that, for ease of discussion and explanation, the foregoing figures show exaggerated deformations and curvatures of the ridges, while actual deformations and curvatures may be much subtler and less acute.

In some embodiments, one or more ridges 17 are also configured with hinges 90 for in-plane (side-to-side) deflection. As shown in Figures 11A and 11B, the ridge 17 may have a plurality of notches or grooves along opposing lateral edges, including an expandable groove 80 (eg, a slit 81 and a circular opening 82) along one edge 85a form) and compressible grooves 83 (eg, in the form of slots 84 and circular openings 82) along opposing edges 85b, thereby forming hinges 90 for more in-plane deflection along these edges. In the embodiment of FIGS. 11A and 11B , a unidirectional deflection occurs towards the edge 85b of the ridge 17 . It should be appreciated, however, that where compressible grooves 83 are formed along both edge 85a and edge 85b, ridge 17 has a bidirectional deflection towards either edge 85a or 85b. Suitable hinges are described in US Pat. No. 7,276,062, which is incorporated herein by reference in its entirety.

As shown in Figures 12A and 12B, each ridge 17 of the distal electrode assembly 15 is surrounded by a non-conductive ridge cover or tube 28 along its length. In some embodiments, the non-conductive spine cover 28 comprises a very soft and highly flexible biocompatible plastic, such as PEBAX or PELLATHANE, and the spine cover 28 is mounted on the spine, its length along with the spine extending between the rod 42 and the enlarged coextensive between the distal portions 46 . Suitable materials of construction for the spine cover 28 are sufficiently soft and flexible so as not to generally interfere with the flexibility of the spine 17 .

In some embodiments, each covered ridge 17 has a diameter D along its length of less than 3 French, preferably a diameter of less than 2.7 French, and more preferably a diameter of 2 French (eg, between about 0.025 inches and 0.035 inches in diameter).

Each ridge 17 includes an atraumatic distal cover or cap 45 that encloses the enlarged distal portion 46 (see Figure 12A). In some embodiments, cover 45 includes a biocompatible adhesive or sealant, such as polyurethane, that has a bulbous configuration to minimize contact with tissue or against Damage to tissue when pressure is applied to the tissue. The construction of the cover 45 includes a bridge portion 63 of adhesive or sealant that passes through the through hole 47 in the enlarged distal portion 46 and advantageously forms a mechanism for securing the cover 45 to the distal portion 46 lock and minimize the risk of the cover 45 becoming detached from the enlarged distal portion 46 .

Each ridge 17 carries a plurality of microelectrodes 18 . The number and arrangement of microelectrodes can vary depending on the intended use. In some embodiments, "plurality" is in the range between about 48 and 72, although it is understood that "plurality" can be larger or smaller. In some embodiments, each microelectrode has a length L of less than 800 μm (eg, in the range between about 600 μm and 300 μm, and eg, measured about 480 μm, 460 μm, or about 450 μm). In some embodiments, the distal electrode assembly 15 has an area coverage greater than about 7.1/cm ² (eg, in the range between about 7.2/cm ² and 12.6/cm ² ). In some embodiments, the distal electrode assembly 15 has microelectrodes greater than about 2.5 microelectrodes/cm ² (eg, in the range between about 4 microelectrodes/cm ² and 7 microelectrodes/cm ² ) electrode density.

In some embodiments, the distal electrode assembly 15 has eight ridges, each ridge is about 1.5 cm in length and carries eight microelectrodes for a total of 48 microelectrodes, the microelectrodes of each ridge having a length of about 460 μm, The assembly 15 has an area coverage of about 7.1/cm ² and a microelectrode density of about 7 microelectrodes/cm ² .

In some embodiments, the distal electrode assembly 15 has eight ridges, each ridge is about 2.0 cm in length and carries six microelectrodes for a total of 48 microelectrodes, the microelectrodes of each ridge having a length of about 460 μm, The assembly 15 has an area coverage of about 12.6/cm ² and a microelectrode density of about 4 microelectrodes/cm ² .

The microelectrodes 18 on the ridges 17 may be arranged as monopoles or dipoles with various spacings between them, where the spacing is measured as the spacing between respective leading edges of adjacent microelectrodes or pairs of microelectrodes. As monopoles, the microelectrodes 18 may be separated by a distance S1 ranging between about 1 mm and 3 mm, see Figure 12A. As bipolar, adjacent pairs of microelectrodes 18 may be separated by a distance S2 in the range between 1 mm and 6 mm, see Figure 12B.

In some embodiments, referring to FIG. 12B , six microelectrodes are arranged in three bipolar pairs, the spacing S1 between the proximal edges of the bipolar pairs is 2.0 mm, and the distance between the proximal edges of adjacent bipolar pairs is 2.0 mm. The spacing S2 between them is 6.0 mm, and these three bipolar pairs can generally be referred to as a "2-6-2" configuration. Another configuration, referred to as the "2-5-2-5-2" configuration, has three bipolar pairs, where the spacing S1 between the proximal edges of the bipolar pairs is 2.0 mm, and adjacent bipolar pairs are The spacing S2 between the proximal edges is 5.0mm.

In some embodiments, referring to FIG. 12A, six microelectrodes are arranged as monopoles, wherein the spacing S1 between the proximal edges of adjacent monopoles is 2.0 mm, which monopoles may be referred to as "2-2- 2-2-2" configuration. In some embodiments, the spacing S1 is about 3.0 mm, hence the term "3-3-3-3-3" configuration.

In some embodiments, the proximal-most microelectrode 18P of each ridge is carried on the ridge at a different location than the proximal-most microelectrode 18P of an adjacent ridge. As shown in Figure 13, although the spacing between the microelectrodes on any one ridge may be uniform throughout the distal electrode assembly, the microelectrodes along any one ridge are staggered relative to the microelectrodes along an adjacent ridge (or offset). For example, for ridges 17A, 17C, 17E, and 17G, the distance D1 between the proximal-most microelectrode 18P and the end of rod 42 is greater than the distance between the proximal-most electrode 18P and the end of rod 42 for ridges 17B, 17D, 17G, and 17G distance D2. This staggered configuration minimizes the risk of microelectrodes touching and shorting on adjacent ridges, especially when the operator sweeps the distal electrode assembly against tissue. Furthermore, this staggered configuration provides a larger effective contact surface for the distal electrode assembly 15 because the effective concentric electrode array is doubled (see Figure 13). Referring to Figures 13, 26 and 27, the interleaving can take on different configurations depending on factors including the distance or spacing between adjacent electrodes on any one ridge. In some embodiments, each ridge can exhibit a unique staggered configuration (FIG. 27). In some embodiments, one or more ridges may exhibit the same staggered configuration as long as the ridges are not adjacent to each other and are separated by at least one or more ridges having a different staggered configuration (see, eg, FIG. 26 ). Concentricity in C1, C2, C3 and C4). In this regard, the spacing between adjacent electrodes along any one ridge can be non-uniform, as long as the spacing between adjacent electrodes along adjacent ridges is different and the electrodes of adjacent ridges are located on different concentricities That's it. The staggered configuration also includes configurations in which the concentric traces of the electrodes of any one ridge around the longitudinal axis of the assembly 15 are different from the concentric traces of the electrodes of any adjacent ridge.

The configuration of the interface between the distal electrode assembly and the distal portion of the deflection segment 14 and components of the assembly are described in US Pat. Nos. 7,089,045, 7,155,270, 7,228,164, and 7,302,285, the entire disclosures of which are incorporated by reference in their entirety. This article. As shown in FIG. 14A , the rod 42 of the unitary support member 40 receives the narrowed distal end 30D of the multi-lumen tube 30 of the deflection segment 14 . A non-conductive sleeve 68 circumferentially surrounds the rod 42, the non-conductive sleeve coextensive with the rod between its proximal and distal ends. The distal end 68D of the sleeve 68 extends over the proximal end 28P of the non-conductive spine tube 28 to assist in securing the tube 28 to the spine 17 .

Proximal of the distal end 30D is a housing insert 60 that is also received and positioned in the lumen 43 of the stem 42 of the integral support member 40 . The length of the housing insert 60 in the longitudinal direction is shorter than the length of the rod 42 so that the housing insert does not protrude beyond the distal end of the rod 42 . The housing insert 60 is configured to have one or more lumens. One lumen 71 may have a non-circular cross-section, eg, substantially similar to that of a "C" or elongated kidney bean, and the other lumen 72 may have a circular cross-section, as shown in Figure 14B, such that these tubes The lumens may be nested within each other to maximize the size of these lumens and increase space efficiency within the housing insert 60 . Components passing through more lumens 71 are not constrained to any one position or orientation, thus having greater freedom of movement and less risk of fracture, especially when sections of the catheter are twisted and components are twisted.

In some embodiments, electromagnetic position sensor 26 (at the distal end of cable 24 ) is received in lumen 72 . Other components include, for example, irrigation tube 27 and lead 22 for microelectrode 18 on distal electrode assembly 15 (and lead 25 for any ring electrodes 67, 69, and 70 proximal to spine 17) through lumen 71. In this regard, housing insert 60 serves a variety of functions, including aligning and positioning various components within rod 42 of integral support member 40; providing spacing for and between these various components Separate and serve as a mechanical lock that enhances the junction between the distal end of the deflection segment 14 and the distal electrode assembly 15 . In the latter case, during assembly and use of the catheter, the junction may be subjected to various forces that may twist or pull on the junction. For example, the twisting force may pinch the irrigation tube 27 to prevent flow, or cause the leads 22 and 25 to break. To this end, the joint is advantageously assembled in a configuration with the housing insert 60 to form a mechanical lock, as explained below.

The housing insert 60 may optionally be configured to have an outer diameter that is smaller than the inner circumference of the lumen 43 of the rod 42 by a predetermined amount. This creates a perceptible void in lumen 43 that is filled with a suitable adhesive 61, such as polyurethane, to securely attach housing insert 60 inside lumen 43 and to the multi-lumen The distal end of the tube 30 in order to minimize, if not prevent, relative movement between the insert 60 and the rod 42 . Housing insert 60 protects the components it surrounds, including electromagnetic position sensor 26 (and its attachment to cable 24), irrigation tube 27, and leads 22 and 25, and provides greater and more rigidity to which rod 42 is attached Structure. To this end, the housing insert 60 may even have a non-circular/polygonal outer cross-section and/or a textured surface to improve the attachment between the housing insert 60 and the adhesive 61 .

To facilitate application of the adhesive into the void, the stem 42 is formed with an opening 65 in its sidewall at a location that allows for the housing after the housing insert 60 has been inserted into the lumen 43 of the stem 42 Inserts provide visual and mechanical access. During assembly of the joint, visual inspection of lumen 43 and the components therein is provided through opening 65 . Although any adhesive applied to the outer surface of housing insert 60 prior to insertion into lumen 43 may spray from stem 42 during insertion, additional adhesive may advantageously be applied to lumen 43 through opening 65 to fill the void and thus securely attach the housing insert 60 to the stem 42 and the distal portion of the multi-lumen tube 30 . The combination of the housing insert 60 and its space-receiving lumen 71 provides a more integrated and less damaged interface between the distal electrode assembly 15 and the deflection segment 14 .

In some embodiments, catheter 10 includes irrigation tube 27 whose distal end 27D is generally coextensive with the distal end of rod 42 of integral support member 40 . Accordingly, irrigation fluid (eg, saline) is delivered to the distal electrode assembly 15 from a remote fluid source via the luer 100 ( FIG. 1 ) via the irrigation tube 27 extending through the control handle 16 , the center of the catheter body 12 . Lumen 19 ( FIG. 2 ) and lumen 31E ( FIG. 3 ) of tube 30 of deflection segment 14 provide irrigation fluid, in this case at the distal end of rod 42 of integral support member 40 Exit the distal end of the irrigation tube 27 as shown in FIGS. 15A and 25 . A suitable adhesive, such as polyurethane, plugs and seals lumen 43 around the distal end of irrigation tube 27 . In some embodiments, the catheter is not flushed and the distal end of the stem 42 of the one-piece support member 40 is integrally sealed with an adhesive or sealant 90, such as polyurethane, as shown in Figure 14A.

FIG. 16 shows an embodiment in which the non-conductive spine 28 includes a reinforced tensile member 53 . As understood by those of ordinary skill in the art, the microelectrodes 18 are mounted on the spine cover or tube 28 with an elongated tubular mandrel (not shown) positioned in the lumen of the spine cover 28 to allow the microelectrode 18 supports these microelectrodes as they are rotationally swaged onto the ridge cover 28. Microelectrodes 18 may have circular cross-sections, including circular or oval configurations. In order to prevent or at least minimize undesired deformation of the microelectrodes 18 and ridge cover 28 during swaging, including elongation in the longitudinal direction, the ridge cover 28 on which the microelectrodes are carried and swaged includes enhanced stretching member 53, as shown in FIG. 16 . Tensile members 53 (eg, wires or fibers (used interchangeably herein)) are embedded in the sidewall 54 of the tube (eg, during extrusion of the tensile members). Tensile members 53 may be embedded in the non-conductive cover extrudate in a uniaxial or woven pattern, extending in the longitudinal direction or at least having portions that extend in the longitudinal direction. Thus, the tensile member serves to resist undesired elongation of the particularly soft and flexible ridge cover 28 and microelectrodes 18 in the longitudinal direction. Examples of suitable tensile members include VECTRAN, DACRON, KEVLAR or other materials with low elongation properties. Multiple reinforcing tensile members are not a critical factor. In some embodiments, "plurality" can range between two and six arranged in a radially equivalent configuration. In the illustrated embodiment, the ridge cover 28 includes four tensile members at 0, 90, 180, and 270 degrees around the sidewall 54 .

In some embodiments, the distal end of tensile member 53 is anchored in bulbous cover 45 that encapsulates the enlarged distal portion of spine 17, and/or ring 99D (shown in FIG. 16) may be compressed or Clamped on ridge cover 28 and ridge 17 . In some embodiments, the proximal end of tensile member 53 is coextensive with the proximal end of spine cover 28 and may also be anchored by loop 99P (see Figures 14A and 15A).

In some embodiments, tensile member 53 has a much greater length. Referring to FIGS. 17 , 18 , 19 and 20 , tensile member 53 extends through opening 44 formed in rod 42 of integral support member 40 and into lumen 43 of rod 42 . Tensile member 53 then extends through lumen 71 of housing insert 60 , lumen 31F of tube 30 of deflection segment 14 and central lumen 19 of catheter body 12 and into control handle 16 . The proximal end of the tensile member 53 is configured to be manipulated by the operator to deflect the ridges 17 of the distal electrode assembly 15 so that they can be used individually as "fingers". In this regard, tensile members may be formed in the sidewall of tube 28 in a manner that allows longitudinal movement relative to tube 28 such that any one or more of the tensile members may be pulled proximally to bring the corresponding ridge toward Those tensile members are bent or deflected along the side on which they extend. Thus, the operator can manipulate one or more ridges for individual deflection as needed or desired, including when the distal electrode assembly is in contact with uneven tissue surfaces, in which case one or more ridges need to be adjusted for better tissue contact.

21, 22, 23, and 24, the catheter 10 of the present invention is shown in use in all four chambers of the heart (ie, left and right atria, left and right ventricles), with the distal The ridges of the electrode assembly 15 readily conform and conform to the various anatomical structures of the heart tissue (including, for example, the interior of the pulmonary veins, as well as on the posterior wall of the right atrium, on the anterior, inferior and/or lateral walls of the left and right ventricles, and the apex of the heart). contours and surfaces. Regardless of the anatomy of the surface, the pre-shaped configuration of the spine advantageously facilitates contact between the microelectrodes carried on the spine and the tissue.

In some embodiments, catheter 10 has a plurality of ring electrodes proximal to distal electrode assembly 15 . In addition to ring electrode 67 , as shown in FIG. 1 , the catheter also carries another ring electrode 69 more proximal than ring electrode 67 , and another ring electrode 70 more proximal than ring electrode 69 . Lead wires 25 are provided for these ring electrodes. In some embodiments, ring electrode 69 is located near distal end 30D of multi-lumen tube 30 of deflection section 14, and ring electrode 70 is spaced apart from ring electrode 69 in a range between about 1 mm and 3 mm distance S. The respective leads 25 are connected to the ring electrodes 67 via openings 75 formed in the rod 42 of the integral support member 40 and in the sleeve 68 . The respective leads 25 for the ring electrodes 69 and 70 are connected to via openings (not shown) formed in these side walls of the tube 30 of the deflection segment 14 .

Each portion of puller wires 23A and 23B extending through catheter body 12 is circumferentially surrounded by respective compression coils 101A and 101B, as understood in the art. Each portion of the puller wires 23A and 23B extending through the multi-lumen tube 30 of the deflection segment is circumferentially surrounded by a sheath that protects the puller wires from cutting into the tube when the puller wires are deflected middle. As understood in the art, the distal end of the puller wire may be anchored in the sidewall of the tube 30 at or near the distal end of the tube 30 . As understood in the art, the proximal end of the puller wire is anchored in the control handle 16 for actuation by the operator of the catheter.

The foregoing description has been presented with reference to presently preferred embodiments of the invention. Those skilled in the art to which this invention pertains will appreciate that changes and modifications to the described structures can be made without intentionally departing from the spirit, spirit and scope of this invention. Any feature or structure disclosed in one embodiment may be incorporated as needed or appropriate in place of or in addition to other features of any other embodiment. As will be understood by those of ordinary skill in the art, the figures are not necessarily drawn to scale. Therefore, the above-described detailed description should not be construed as being suitable only for the precise structures described and illustrated in the accompanying drawings, but should be construed in accordance with and in support of the following claims, which have the present Full and equitable scope of the invention.

Claims (20)

1. An electrophysiology catheter comprising:

an elongated body;

a distal electrode assembly, the distal electrode assembly comprising:

a proximal shaft defining a circumference about a longitudinal axis; and

a plurality of ridges emanating from the proximal shaft and diverging at a distal end thereof, the plurality of ridges alternating between first and second ridges around the circumference of the shaft;

a plurality of non-conductive ridge covers, each ridge cover surrounding a respective ridge; and

a plurality of microelectrodes having a staggered configuration between the first and second ridges, wherein a most proximal microelectrode on each first ridge is positioned at a greater distance from the proximal bar and a most proximal microelectrode on each second ridge is positioned at a lesser distance from the proximal bar.

2. The catheter of claim 1, wherein the distal electrode assembly comprises at least four first ridges and four second ridges, and each ridge carries six microelectrodes.

3. The catheter of claim 1, wherein the microelectrodes on the first ridge have a first separation distance from each other and the microelectrodes on the second ridge have a second separation distance, wherein the first separation distance is substantially the same as the second separation distance.

4. The catheter of claim 1, wherein the microelectrodes on the first ridge have a first separation distance from each other and the microelectrodes on the second ridge have a second separation distance, wherein the first separation distance and the second separation distance are different.

5. The catheter of claim 1, wherein the microelectrode is configured as a monopolar.

6. The catheter of claim 1, wherein the microelectrodes are configured as bipolar.

7. An electrophysiology catheter comprising:

an elongated body;

a distal electrode assembly including a support body having:

a proximal shaft;

a plurality of ridges spanning outwardly from the stem, each ridge carrying a plurality of microelectrodes, each electrode defining a concentricity, wherein the concentricity of a microelectrode on one ridge is different from the concentricity of microelectrodes on an adjacent ridge.

8. The electrophysiology catheter of claim 7 wherein the plurality of microelectrodes carried on each ridge are identical.

9. The electrophysiology catheter of claim 7 wherein said plurality of microelectrodes carried on adjacent spines are different.

10. The electrophysiology catheter of claim 7 wherein said plurality of ridges is eight.

11. The electrophysiology catheter of claim 7 wherein said plurality of microelectrodes on each ridge is six.

12. The electrophysiology catheter of claim 7 wherein said plurality of ridges ranges between about six and eight.

13. The electrophysiology catheter according to claim 7 wherein said plurality of microelectrodes ranges between about six and eight.

14. The catheter of claim 7, wherein the microelectrodes on each ridge are separated by a distance in a range between about 1mm and 3mm as measured between leading edges of the microelectrodes.

15. The catheter of claim 14, wherein the distance is about 2 mm.

16. The catheter of claim 7, wherein the microelectrodes on each ridge are arranged in bipolar pairs, wherein leading edges of microelectrodes within a pair are separated by a first distance in a range between about 1mm and 3mm, and wherein leading edges of leading microelectrodes between pairs are separated by a second distance in a range between 1mm and 6 mm.

17. The catheter of claim 16, wherein the first distance is about 2mm and the second distance is about 6 mm.

18. The catheter of claim 7, wherein the plurality of microelectrodes is equal to about 64.

19. The catheter of claim 7, wherein the plurality of microelectrodes is equal to about 72.

20. The catheter of claim 7, further comprising:

a first ring electrode carried on the proximal shaft of the distal electrode assembly; and

a second ring electrode and a third ring electrode carried on a distal portion of the elongate body.

Images